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Pulse Generator, Model No. LIT 222

by Bentley Laboratories, Inc.

510(k) K792526

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792526 Date5 Feb 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Implantable Pacemaker Pulse-Generator, classified as a Class III medical device under 21 CFR 870.3610. It generates electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders, ensuring consistent cardiac pacing when the natural pacemaker fails.

The Pulse Generator, Model No. LIT 222 is intended for surgical implantation and is designed as a reusable component within a pacemaker system. It requires sterile handling during surgical procedures and is regulated under FDA 510(k) clearance (K792526) with a traditional review pathway. No MRI safety or single-use specifications are noted in the regulatory data.

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